NORTH FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [NORTH SAFETY PRODUCTS]

NORTH FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [NORTH SAFETY PRODUCTS]
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NDC 0498-0015-40
Set ID 109e0046-eb93-445b-a224-af897a5a0793
Category HUMAN OTC DRUG LABEL
Packager North Safety Products
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Benzethonium chloride 0.02% w/w

    Benzocaine 10% w/w

  • Purpose

    Topical antiseptic

    Topical anesthetic

  • Uses

    for temporary relief of pain and itching and helps protect against infection in:

    • minor cuts and scrapes
    • insect bites
    • minor skin irritations
  • Warnings

    For external use only

    Flammable

    • keep away from fire or flame
    • contents under pressure
    • do not puncture or incinerate container
    • do not expose to temperatures above 120o F

    Do not use

    • in or near the eyes or other mucus membranes
    • in case of serious burns
    • in case of deep or puncture wounds
    • for prolonged period of time
    • on large portion of the body

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • condition clears up and recurs within a few days
    • redness, swelling or irritation occurs

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • clean the affected area
    • shake can well before using
    • hold 4 - 6 inches from surface and spray area until wet
    • may be covered with a sterile bandage, if bandaged let dry first
    • for adult institutional use only
    • not intended for use on children
  • Other information

    • avoid inhaling
    • use only as directed
    • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal
  • Inactive ingredients

    dipropylene glycol, isobutane, n-butane, propane

  • Principal Display Panel

    image of pdpEnter section text here

  • INGREDIENTS AND APPEARANCE
    NORTH FIRST AID ANTISEPTIC  
    benzalkonium chloride, benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0015-4085 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2013
    Labeler - North Safety Products (019777263)
    Establishment
    NameAddressID/FEIBusiness Operations
    North Safety Products019777263manufacture(0498-0015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dixon Investments115315822manufacture(0498-0015)

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